Early Stage Ovarian TumorsPONDERNCT07271914
PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors
A study testing systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach and Histopathologic Analysis in people with Early Stage Ovarian Tumors and Peritoneal Carcinosis, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
Trial summary
Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Ovarian Tumors, Peritoneal Carcinosis
- What is being tested?
- systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach and Histopathologic Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2026to Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors
- Complete preoperative work-up (ultrasound, CT scan, tumor markers)
- Laparoscopic, robotic or open surgical approach
- Signed informed consent
Who cannot join
- Sarcomas, melanomas, mesotheliomas, hematologic malignancies
- Advanced ovarian tumors
- Fertility-sparing surgery with uterine preservation
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliera Santa Croce e Carle Cuneo
Cuneo
Silvia Violante, MD, 00390171641539, violante.s@ospedale.cuneo.it
About this study
Official title: Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study
Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens
Read the detailed description
The study focuses on the excision of anatomically defined pelvic peritoneal areas, with meticulous dissection of the retroperitoneal spaces and a nerve-sparing approach. Combined with a specific pathology protocol, this strategy improves the detection of microscopic peritoneal involvement and provides new insights into the mechanisms of pelvic recurrence
- Conditions
- Early Stage Ovarian Tumors, Peritoneal Carcinosis
- Being tested
- systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach, Histopathologic Analysis
- Keywords
- ovarian cancer, early stage, ovarian tumor, peritoneal carcinosis, pathology assessment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approachProcedure or surgery
Surgical Procedure:
Initial step: Exclude upper abdominal disease through inspection and guideline-based biopsies.
Pelvic peritoneal resection: En bloc or segmental removal of predefined pelvic peritoneal regions according to dissection of retroperitoneal spaces with a nerve-sparing technique.
Histopathologic AnalysisDiagnostic test
Fixation: 10% neutral-buffered formalin for 6-48 hours. Processing: Paraffin eembedding and complete sampling for histology. Staining: H\&E and immunohistochemistry (MOC-31, BER-EP4) to identify epithelial tumor cells. Reporting: Checklist for peritoneal disease
| Study group | Role | What they receive |
|---|---|---|
| Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma | Other | All patients will receive standard pre-, intra-, and postoperative care according to institutional guidelines. The peritonectomy procedure will not alter the choice of surgical access. Pelvic peritonectomy specimens will be analyzed as part of the final pathology report. Receives: Procedure: systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach; Diagnostic Test: Histopathologic Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants)
Measured: from surgery up to at least 24 months of follow up after surgery
Secondary outcomes (4)
Perioperative complications
Clavien-Dindo classification
Measured: from the date of surgery up to six months after surgery
Recurrence site
Measured: from the date of surgery up to at least 24 months of follow up
2-year progression free survival
Measured: 24 months after surgery
2-year overall survival
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startFeb 2026 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Stage Ovarian TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention Model: Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Croce-Carle Cuneo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Olearo, Ospedale Santa Croce-Carle Cuneo
- Investigators
- Andrea Puppo, MD, Principal investigator, Azienda Ospedaliera Santa Croce e Carle CuneoElena Olearo, MD, Study director, Azienda Ospedaliera Santa Croce e Carle Cuneo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271914
- Sponsor's protocol ID
- CnGin20251
- Acronym
- PONDER
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be shared with investigators from other centers and results published according to national and international regulatory requirements
Publications
van de Vorst REWM, Hoogendam JP, van der Aa MA, Witteveen PO, Zweemer RP, Gerestein CG. The attributive value of comprehensive surgical staging in clinically early-stage epithelial ovarian carcinoma: A systematic review and meta-analysis. Gynecol Oncol. 2021 Jun;161(3):876-883. doi: 10.1016/j.ygyno.2021.04.007. Epub 2021 Apr 10.
PubMed 33849726
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study
- ClinicalTrials.gov ID
- NCT07271914
- Acronym / sponsor ID
- PONDER / CnGin20251
- Conditions
- Early Stage Ovarian Tumors, Peritoneal Carcinosis
- Keywords
- ovarian cancer, early stage, ovarian tumor, peritoneal carcinosis, pathology assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Ospedale Santa Croce-Carle CuneoUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens
Detailed description
The study focuses on the excision of anatomically defined pelvic peritoneal areas, with meticulous dissection of the retroperitoneal spaces and a nerve-sparing approach. Combined with a specific pathology protocol, this strategy improves the detection of microscopic peritoneal involvement and provides new insights into the mechanisms of pelvic recurrence
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention Model: Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma | Other | Procedure: systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach, Diagnostic Test: Histopathologic AnalysisAll patients will receive standard pre-, intra-, and postoperative care according to institutional guidelines. The peritonectomy procedure will not alter the choice of surgical access. Pelvic peritonectomy specimens will be analyzed as part of the final pathology report. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors
- Complete preoperative work-up (ultrasound, CT scan, tumor markers)
- Laparoscopic, robotic or open surgical approach
- Signed informed consent
Key exclusion criteria (4 listed)
- Sarcomas, melanomas, mesotheliomas, hematologic malignancies
- Advanced ovarian tumors
- Fertility-sparing surgery with uterine preservation
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approachSurgical Procedure: Initial step: Exclude upper abdominal disease through inspection and guideline-based biopsies. Pelvic peritoneal resection: En bloc or segmental removal of predefined pelvic peritoneal regions according to dissection of retroperitoneal spaces with a nerve-sparing technique. | Procedure or surgery | Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma |
| Histopathologic AnalysisFixation: 10% neutral-buffered formalin for 6-48 hours. Processing: Paraffin eembedding and complete sampling for histology. Staining: H\&E and immunohistochemistry (MOC-31, BER-EP4) to identify epithelial tumor cells. Reporting: Checklist for peritoneal disease | Diagnostic test | Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma |
Primary outcome
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).
Time frame: from surgery up to at least 24 months of follow up after surgery
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants)
4 secondary outcomes
Perioperative complications
Time frame: from the date of surgery up to six months after surgery
Recurrence site
Time frame: from the date of surgery up to at least 24 months of follow up
2-year progression free survival
Time frame: 24 months after surgery
2-year overall survival
Time frame: 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Results publication: PubMed 33849726van de Vorst REWM, Hoogendam JP, van der Aa MA, Witteveen PO, Zweemer RP, Gerestein CG. The attributive value of comprehensive surgical staging in clinically early-stage epithelial ovarian carcinoma: A systematic review and meta-analysis. Gynecol Oncol. 2021 Jun;161(3):876-883. doi: 10.1016/j.ygyno.2021.04.007. Epub 2021 Apr 10.
- Individual participant dataSharing planned: Yes. Study data will be shared with investigators from other centers and results published according to national and international regulatory requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Puppo, MD principal investigator
Azienda Ospedaliera Santa Croce e Carle Cuneo
Elena Olearo, MD study director
Azienda Ospedaliera Santa Croce e Carle Cuneo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach and Histopathologic Analysis in people with Early Stage Ovarian Tumors and Peritoneal Carcinosis, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Puppo, MD (00390171642867, puppo.a@ospedale.cuneo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants). (time frame: from surgery up to at least 24 months of follow up after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.